Search results for "Analytical data" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
Article
Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Spivey and Lane
Click here to view more Q&As >>
Analytic considerations for upstream processing – covering Process Analytic Technology (PAT), time-savings versus off-line ana…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
Using Modeling to Improve Data Analytics for Upstream Bioprocessing Workflows
Recent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.
READ MORE >>
Article
Recent Trends in Data Analytics for Upstream Process Workflows
Modeling techniques can improve process control and monitoring in biopharmaceutical production.
Read more about it here >>
Article
Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…
Article
Analytical SEC: How Does Back Pressure Relate to Resolution?
High resolution in HPLC is not achieved by applying back pressure to the column. Let’s straighten out what really helps you achieve high-resolution analytical SEC data.
Read paper